NDC codes

FDA NDC Directory
Product NDC (as listed)0169-2001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00169-2001Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0169-2001-9000169200190001692001901 VIAL, GLASS in 1 CARTON (0169-2001-90) / 10 mL in 1 VIAL, GLASSMarketed from Aug 1, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Insulin Diluting Medium for NovoLog
Generic name (nonproprietary)
water injection
Active ingredients
Water — 1 mL/mL
Dosage form
Injection, Solution
Route
Intravenous, Subcutaneous
Labeler
Novo NordiskNDC labeler code 0169
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 020986
Marketing start
Listing expires
Identifiers
Product ID 0169-2001_de82c22d-ea25-44ef-8bcd-c3cda9e84e59SPL ID de82c22d-ea25-44ef-8bcd-c3cda9e84e59SPL set ID 3a1e73a2-3009-40d0-876c-b4cb2be56fc5RxCUI 311040, 351926, 1653196, 1653198, 1653202, 1653204UNII D933668QVX, 059QF0KO0R

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400169200190 followed by a unit qualifier and the quantity

Package 00169-2001-90. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0169-2001

What is NDC 0169-2001?
0169-2001 is the product NDC for Insulin Diluting Medium for NovoLog, Water 1 mL/mL injection, solution, listed with the FDA by Novo Nordisk. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Insulin Diluting Medium for NovoLog (Water injection).
What is the active ingredient?
Water.
Who is the labeler?
Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Insulin Diluting Medium for NovoLog?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under BLA 020986

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 020986
ProductStrengthForm · routeLabelerProduct NDC
Insulin AspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-4955
Insulin AspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-4956
Insulin AspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousREMEDYREPACK INC.70518-3865
Insulin AspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk Pharma, Inc.73070-100
Insulin AspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk Pharma, Inc.73070-102
Insulin AspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk Pharma, Inc.73070-103
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk0169-2100
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk0169-2101
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk0169-3303
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk0169-6338
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk0169-6339
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousNovo Nordisk0169-7501
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-1664
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-1678
Novologinsulin aspartInsulin aspart 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-4500

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